Whole body washing to reduce skin-surface bacteria: pilot study in healthy volunteers
| ISRCTN | ISRCTN25160191 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25160191 |
| Protocol serial number | N/A |
| Sponsor | De Montfort University (UK) |
| Funder | Molnlycke Health Care (UK) |
- Submission date
- 31/03/2010
- Registration date
- 07/04/2010
- Last edited
- 31/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Judith Tanner
Scientific
Scientific
Charles Frears Campus
266 London Road
Leicester
LE2 1RQ
United Kingdom
| jtanner@dmu.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomised active controlled parallel-group trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of three body washing products to reduce bacterial colony forming units on skin: a pilot study in healthy volunteers |
| Study objectives | What is the difference in the reduction of colony forming units on skin between three body washing products, using pre-intervention and three post intervention time points? This is a pilot study to investigate which product is most effective at reducing bacteria on skin. Skin bacteria can cause surgical site infections. |
| Ethics approval(s) | Faculty of Health and Life Sciences Research Ethics Committee, De Montfort University, 04/02/2010, ref: 584 |
| Health condition(s) or problem(s) studied | Surgical site infections |
| Intervention | Participants randomised to 1 of 3 groups using random number tables and sequentially numbered sealed envelopes 1. Group 1 Control: Plain soap and plain shampoo Participants shower daily for two days using the following instructions - Enter shower, ensure body and hair are wet. Apply 25mls soap to body, rinse and repeat using another 25mls. Wash hair. Rinse thoroughly. Dry with a clean towel. 2. Group 2 Intervention: Hibiscrub® Plus Participants shower daily for two days following manufacturers instructions - Enter shower, ensure body and hair are wet. Apply 25mls Hibiscrub® Plus to body, rinse and repeat using another 25mls. Wash hair. Rinse thoroughly. Dry with a clean towel. 3. Group 3 Intervention: Octenisan® Participants shower daily for five days following manufacturers instructions - Enter shower, ensure body and hair are wet. Apply Octenisan® to a damp cloth and apply to body. Leave for 3 minutes before rinsing thoroughly. Wash hair with Octenisan® on day 2 and day 4. Dry with a clean towel. |
| Intervention type | Other |
| Primary outcome measure(s) |
Colony forming units from swabs taken from nose, armpit and groin pre-intervention and post intervention at 0 hours, 4 hours and 6 hours. |
| Key secondary outcome measure(s) |
None |
| Completion date | 21/05/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Healthy volunteers from De Montfort University - staff or students 2. Any age and either sex |
| Key exclusion criteria | 1. Allergic to soaps, Hibiscrub® Plus or Octenisan® 2. Has an open wound 3. Currently taking antibiotics or has taken antibiotics in the previous week 4. Has a respiratory infection 5. Has a skin infection 6. Wears jewellery in nose 7. Wears moisturiser, body lotion or any other antiseptic skin product |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 21/05/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
De Montfort University
Leicester
LE2 1RQ
United Kingdom
LE2 1RQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | 31/10/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/10/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
05/07/2016: No publications found, verifying study status with principal investigator.
